Header
- Model name
- Hormonal Imbalance (Female)
- Developer
- Zenlo LLC
- Release stage
- Research Tool (not FDA-cleared)
- Version
- 1.0
- Availability
- United States
- Regulatory status
- Not applicable — academic and transparency positioning
- Pattern slug
- hormonal_female
- Biomarkers
- ESTRADIOL, FSH, PROGEST, CORTISOL, CORT, DHEAS
This document follows the CHAI Applied Model Card format (v0.1).
Summary
The Hormonal Imbalance (Female) pattern evaluates estradiol, FSH, progesterone, cortisol, and DHEA-sulfate in adult female laboratory panels, flagging reproductive-axis or adrenal signals for physician review. Deterministic rules apply cycle-phase–aware and sex-specific comparisons where encoded in the detector. Claude Haiku 4.5 provides narrative synthesis on contributing hormonal markers. For licensed functional-medicine physicians, this is supportive clinical decision support — it does not diagnose menopause, PCOS, or adrenal disorders, and it does not guide hormone therapy. Outputs highlight endocrine laboratory abnormalities requiring correlation with menstrual history, cycle day, symptoms, and expanded testing.
Uses & Directions
Intended use
Clinical decision support for licensed physicians reviewing female sex-hormone and adrenal marker patterns in adult panels.
Primary users
Licensed functional medicine physicians and similarly qualified clinicians.
How to use
Correlate flagged hormones with cycle day, menopausal status, symptoms, and medications; repeat timed collections as indicated.
Target population
Adults aged 18 and older in the United States.
Out of scope
- Direct patient use without physician oversight
- Male or pediatric endocrine evaluation
- Standalone diagnosis or hormone replacement prescribing
- Fertility treatment protocol management
Warnings
Clinical risk level
Low — supportive tool; the treating physician retains full clinical judgment and responsibility.
Known limitations
- Estradiol and progesterone vary dramatically by cycle phase; undated samples limit interpretation.
- Does not incorporate AMH, prolactin, or androgen excess markers in this pattern.
- Cortisol depends on collection timing and acute stress.
Validation note
Validation pending — a Tier A NHANES validation run has not yet been completed for this pattern. Distribution, agreement, and fairness results will be published here when available.
Trust Ingredients
AI system facts
- Deterministic pattern detector (hormonal_female) plus Claude Haiku 4.5 for narrative synthesis
- Primary inputs: Estradiol, FSH, progesterone, cortisol, and DHEA-sulfate from structured extraction.
- Output: Pattern flag plus narrative on female hormonal marker abnormalities.
Security & compliance
- Anthropic Business Associate Agreement with zero-data-retention configuration
- HIPAA-aligned design; no patient data used for model training
Ongoing maintenance
Versioned, transparent, and reproducible via a public independent audit harness (see Resources).
Transparency
Self-funded development; no third-party sponsor for this pattern card.
Key Metrics
Usefulness / Efficacy
Zenlo's detection approach was benchmarked across five models in a separate study; see the medRxiv preprint in Resources. No per-pattern efficacy metric is published for this pattern.
Source: 5-model benchmark, medRxiv MEDRXIV/2026/346284
Fairness / Equity
Validation pending — a Tier A NHANES validation run has not yet been completed for this pattern. Distribution, agreement, and fairness results will be published here when available.
Safety / Reliability
- Supportive-only; not intended as a standalone diagnostic
- Physician authorization required before clinical use
- Deterministic detector is reproducible for inputs: ESTRADIOL, FSH, PROGEST, CORTISOL, CORT, DHEAS
Resources
- medRxiv preprint MEDRXIV/2026/346284 — 5-model benchmark (system-level detector evaluation)
- JAMIA Open submission JAMIO-2026-0120 (under review)
- Independent audit harness: github.com/dimashibakov/zenlo-audit — reproducibility manifest, NHANES 2015–2016 cycle, harness commit c10afe8
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